For prevention of exercise-induced bronchospasm, the recommended dosage for adults and children 4 years of age orolder is 2 inhalations 15 to 30 minutes before exercise.
2.3 Administration Information
Administer ProAir Digihaler by oral inhalation only.
Priming: ProAir Digihaler inhaler does not require priming.
Do not use ProAir Digihaler with a spacer or volume holding chamber.
Cleaning:
• Keep the inhaler clean and dry at all times. Never wash or put any part of your inhaler in water.
• Routine maintenance is not required. If the mouthpiece needs cleaning, gently wipe the mouthpiece with a drycloth or tissue as needed.
Dose Counter: ProAir Digihaler inhaler has a dose counter attached to the actuator. When the patient receives the inhaler,the number 200 will be displayed. The dose counter will count down each time the inhaler is actuated. When the dosecounter reaches 20, the color of the numbers will change to red to remind the patient to contact their pharmacist for a refillof medication or consult their physician for a prescription refill. When the dose counter reaches 0, the background will
change to solid red. Discard ProAir Digihaler 13 months after opening the foil pouch, when the dose counter displays 0 orafter the expiration date on the product, whichever comes first [see Patient Counseling Information (17)].
Storage of Data on Inhaler Events: ProAir Digihaler contains a built-in electronic module which detects, records, andstores data on inhaler events, including peak inspiratory flow rate (L/min), for transmission to the mobile App whereinhaler events are categorized. Use of the App is not required for administration of albuterol sulfate to the patient. Thereis no evidence the use of the App leads to improved clinical outcomes, including safety and effectiveness [see HowSupplied/Storage and Handling (16)].
3 DOSAGE FORMS AND STRENGTHS
Inhalation Powder: ProAir Digihaler is a multi-dose breath-actuated dry powder inhaler that meters 117 mcg of albuterolsulfate (equivalent to 97 mcg of albuterol base) from the device reservoir and delivers 108 mcg of albuterol sulfate(equivalent to 90 mcg of albuterol base) from the mouth piece per actuation. Each inhaler is supplied for 200 inhalationdoses. ProAir Digihaler inhalation powder is supplied as a white dry powder inhaler with a red cap in a sealed foil pouch.
ProAir Digihaler includes a built-in electronic module [see How Supplied/Storage and Handling (16)].
4 CONTRAINDICATIONS
Use of ProAir Digihaler is contraindicated in patients with a history of hypersensitivity to albuterol and/or severehypersensitivity to milk proteins. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash havebeen reported after the use of albuterol sulfate. There have been reports of anaphylactic reactions in patients usinginhalation therapies containing lactose [see Warnings and Precautions (5.6)].
5 WARNINGS AND PRECAUTIONS
5.1 Paradoxical Bronchospasm
ProAir Digihaler can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasmoccurs, ProAir Digihaler should be discontinued immediately and alternative therapy instituted.
5.2 Deterioration of Asthma
Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needsmore doses of ProAir Digihaler, this may be a marker of destabilization of asthma and requires re-eva luation of the patientand treatment regi |